(262 days)
SuperSlyde lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
SuperSlyde is an anhydrous, non-sterile, clear, silicone-soluble liquid for use as a personal lubricant. It is made of dimethicone and dimethiconol. The specifications for SuperSlyde include appearance, color, odor, viscosity, total aerobic microbial count per USP <61>, total yeast and mold count per USP <61> and absence of pathogenic organisms per USP <62>. Osmolality, pH and antimicrobial effectiveness test parameters are not applicable because the subject lubricant is non-aqueous based formulation. The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, press-top polypropylene (PP) in volumes of 100ml, 250ml and 400ml.
This document is a 510(k) summary for the SuperSlyde Personal Lubricant. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the manner typically expected for AI/ML devices. Instead, it's a regulatory submission for a personal lubricant, focusing on its substantial equivalence to a predicate device based on material composition and physical/chemical properties.
Therefore, I cannot provide the information requested in the prompt, as the prompt's assumptions of an "AI device," "test set," "training set," "ground truth," "experts," and "comparative effectiveness study" are not applicable to the submitted document.
The document discusses the following:
- Device: SuperSlyde Personal Lubricant
- Regulation: Classified under Condom (21 CFR§ 884.5300), Product Code NUC (lubricant, personal)
- Predicate Device: Wet Platinum Premium Lubricant (K130012)
- Performance Testing Summary:
- Biocompatibility: Tested per ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006. Found to be biocompatible.
- Condom Compatibility: Evaluated per ASTM D7661-10. Compatible with natural rubber latex condoms, but not with polyisoprene and polyurethane condoms.
- Shelf Life Testing: Demonstrated the device meets specifications over its proposed shelf life.
These tests are standard for a personal lubricant to demonstrate safety and effectiveness for its intended use, not for an AI/ML device's diagnostic or predictive performance.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 19, 2018
ICM Pharma Pte Ltd Moturi Srinivasa Rao Regulatory Affairs Manager 26 Kallang Place #05-17 Singapore, 339157 Sg
Re: K172306
Trade/Device Name: SuperSlyde Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 15, 2018 Received: March 19, 2018
Dear Moturi Srinivasa Rao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
{1}------------------------------------------------
(Sections 531-542 of the Act); 21 CFR 1000-1050.
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
| EPARTALFood and Drug Administrationndications for Use | Form Approved: OMB No. 0810-0120iration Date: 06/30/2020PRA Statement below. |
|---|---|
| amoux yı) rəqunun (x)Obç | |
| SuperSlyde Personal I.ubricanDevice Name | |
| condoms.si rənbərq sidir. Transpirliyi İstinadlar baş virilər baş virilibi kənd. Bu və sasə əhər sənədlər baş və bir və bir və mərkəzi qaldırılır. Bu nəsirdən bir məsindən bir məsəd əsir məsindən ən çəkindən sənələrin mənon the submitIndications for Use (Desscribe) | |
| Type of Use (Select one or both, as applicable) | |
| Presseription Use (Fran 21 CFR 801 Suppat DA SEDERATE PARA TE PARA TE PAGE IF NEEDED | D Over-The-Counter Use (2) CFR 801 Subpert C |
| A mojation and and the are and of the of the one and and andThis section addition only to respense of the Pagestion Act 1 1665. | |
| : http://www.suiten.com.bullenges.gov.sites in the results that toə bir və bərən mərkəzi və mərkəzi qarşına qarşına qarşı və qarşı və qalan mənistəd bir bulbuların və sunon 87 əgər və orduğu ilə sinfini və isə mərkəzi və əsasən mənist | |
| PRASStaff@ggda.hhs.govPaperwork Reduction Act (PRA) StarfOffice of Chief Information OfficerFood and Drug AdministrationDepartment of Health and Human Services | |
| o uoilsello a not be nound of sound of security of respond to, a collection ofinformation unners it displays a currently valile OMB number | |
| FORM FDA 3881 (TITT)agage 1 of 1 | PSC Pulshishing Services (301) 443-67-10ਜਤ |
{3}------------------------------------------------
510(k) Summary
K172306
| K172306 | ICM PHARMA PTE LTD | |
|---|---|---|
| 26 Kallang Place #05-17 Singapore 339157 | ||
| Submitted by: | ICM Pharma Pte Ltd | Tel: (65) 6296 5411 Fax: (65) 6293 4967 |
| 26 Kallang Place #05-17 | E-mail: icmwi@icmpharma.com | |
| Singapore 339157 | Website: www.icmpharma.com.sg | |
| Contact Person: | Moturi Srinivasa RaoICM Pharma Pte Ltd26 Kallang Place #05-17Singapore 339157Tel: 65-6296-5411Fax: 65-6293-4967email: srinivasa.moturi@icmpharma.com | Co. Regn No: 198601755R |
| Date Prepared: | 08/03/2018 | |
| Proposed TradeName: | SuperSlyde Personal Lubricant | |
| Common Name: | Personal Lubricant | |
| Classification Name: | Condom21 CFR884.5300Class IINUC (lubricant, personal) | |
| Predicate Device | Wet Platinum Premium Lubricant510(k) No: K130012The predicate device has not been subject to a design related recall. | |
| Device Description: | SuperSlyde is an anhydrous, non-sterile, clear, silicone-soluble liquid for use as a personallubricant. It is made of dimethicone and dimethiconol. | |
| The specifications for SuperSlyde include appearance, color, odor, viscosity, total aerobicmicrobial count per USP <61>, total yeast and mold count per USP <61> and absence ofpathogenic organisms per USP <62>. Osmolality, pH and antimicrobial effectiveness testparameters are not applicable because the subject lubricant is non-aqueous basedformulation. | ||
| The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on,press-top polypropylene (PP) in volumes of 100ml, 250ml and 400ml. | ||
| Indications for Use: | SuperSlyde lubricant is a personal lubricant, for penile and/or vaginal application, intended tomoisturize and lubricate, to enhance the ease and comfort of intimate sexual activity andsupplement the body's natural lubrication. This product is compatible with natural rubberlatex condoms. This product is not compatible with polyurethane and polyisoprene condoms. | |
| TechnologicalCharacteristics: | SuperSlyde has similar ingredients to the predicate device. However, SuperSlyde and thepredicate device have different technological characteristics, including their formulation andspecifications. The differences in technological characteristics do not raise differentquestions of safety or effectiveness. | |
| Summary of Performance Testing: | ||
| Biocompatibility: | SuperSlyde Personal Lubricant has undergone biocompatibility testing including cytotoxicity,sensitization, vaginal irritation and acute systemic toxicity testing per ISO 10993-5:2009, ISO10993-10:2010, ISO 10993-10:2010 and ISO 10993-11:2006, respectively. The testing foundthat SuperSlyde Personal Lubricant is biocompatible. | |
| CondomCompatibility | The compatibility of the subject device with natural rubber latex, polyisoprene, andpolyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard TestMethod for Determining Compatibility of Personal Lubricants with Natural Rubber LatexCondoms. The results of this test demonstrated that the subject device is compatible withnatural rubber latex condoms. This product is not compatible with polyisoprene andpolyurethane condoms. | |
| Shelf Life Testing: | The results of shelf life testing demonstrate that the subject device meets its specificationsover the duration of its proposed shelf life. | |
| Conclusion: | The performance data demonstrate that the SuperSlyde Lubricant is substantially equivalentto its proposed predicate device. |
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.